Kornimate/medical-research-clean huggingface dataset:
the urt and middle ear microbiota in health and during chronic ome

Conditions: Otitis Media With Effusion; Healthy

Summary: this study analyses which bacteria are present in the middle ear space and adjacent upper respiratory tract niches in healthy people and in patients suffering from chronic otitis media with effusion (ome; glue ear). the aim is to identify and isolate bacteria that are more common and more abundant in healthy people and to evaluate their potential to protect against bacteria commonly involved in ome and other upper respiratory tract infections. to this end, samples will be collected from both groups (healthy vs ome) and analysed through sequencing of the bacterial 16s gene. in addition, samples obtained from healthy participants will be cultivated to isolate bacteria of interest.


Eligibility criteria:
inclusion criteria: * controls: undergo a surgery that gives access to the middle ear space (at least 30 participants; e.g. cochlear implant recipients) or the adenoids. * ome patients: have fluid accumulation in the middle ear space for 3+ months and receive ventilation tubes. may also undergo adenoidectomy. exclusion criteria: * acute upper respiratory tract infections (including acute otitis media) * chronic upper respiratory tract infections (except ome in patient group) * urt malformations (e.g. as seen in people with down syndrome or cleft palate) * cystic fibrosis * autoimmune diseases or immunodeficiency * pregnancy * use of antibiotics or steroids 1 week before surgery

Keywords: ome otitis media with effusion microbiota microbiome urt upper respiratory tract healthy urt microbiota
endoscopic characteristics of colonic tumours

Conditions: Colonic Polyp; Colon Cancer

Summary: the purpose is to investigate whether polyps that look different at colonoscopy, have formed via different mutations and have different risks of turning into cancer.

laterally spreading tumours (lsts), are polyps that have a lateral extension along the colon wall with minimal vertical growth. it has become evident over the last few years that rather than being a single entity requiring an accumulation of mutations, colon cancer is in fact a heterogenous disease forming via multiple distinct genetic pathways. additionally, with improved endoscopic characterization, it has been noted from experience at westmead hospital that two macroscopically distinct types of lsts, "granular" and "non granular", have different natural histories and risks of invasive cancer. it is therefore hypothesised that different polyp types have different genetic abnormalities, and potentially form via distinct genetic pathways, although this theory has not been widely examined. this knowledge would be important in furthering our understanding of the development of cancer. there is accumulating evidence that genetic abnormalities may be a better predictor of cancer behaviour than histological grade. additionally, guidelines for colonoscopy surveillance are currently a one size fits all approach that do not reflect the genetic heterogeneity of the disease and the knowledge that only 5% of polyps progress to cancer. genetic studies may assess future cancer risk to a person in polyps once removed and plan surveillance colonoscopy frequency. this is an area with interest currently due to the national bowel cancer screening programme, with obvious cost implications for decision makers.

Eligibility criteria:
inclusion criteria: * intention to perform endoscopic mucosal resection * polyp equal to or greater than 20mm * over 18 years of age * able to give informed consent to involvement in trial exclusion criteria: * pregnancy * lactation: currently breastfeeding * taken clopidogrel within 7 days * taken warfarin within 5 days * had full therapeutic dose unfractionated heparin within 6 hours * had full therapeutic dose low molecular weight heparin (lmwh) within 12 hours * known clotting disorder
safety and efficacy of fixed combination phenylephrine-tropicamide for pupil dilation

Conditions: Mydriasis

Summary: subjects will receive ½ of the approved dose of mydcombi to determine the dilation curve with the reduced dose.

mydcombi is approved for inducing mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired. the approved dose is 1 metered spray to the cornea of each eye to be dilated to be repeated after 5 minutes. this study will define the dilation of the pupil with ½ of the approved dose - a single metered spray to the cornea of each eye.

Eligibility criteria:
inclusion criteria: * ability to provide signed written consent prior to participation in any study-related procedures. * ability to return for the study treatment visit. * photopic screening pupil diameter ≤ 3.5 mm in each eye. * females not of childbearing potential or negative pregnancy test exclusion criteria: * pregnant or lactating * clinically significant abnormalities of the eye * active eye disease * using medication that can effect pupil dilation

Keywords: mydriasis
an ai-based mhealth intervention to improve hiv testing

Conditions: HIV Infections

Summary: the purpose of this study is to develop an artificial intelligence (ai)-chatbot-based mobile health (mhealth) intervention to promote hiv testing in malaysia.

a randomized controlled trial (rct) will be conducted in malaysia to assess the efficacy of an ai-chatbot-based mhealth intervention versus treatment as usual (tau) with hiv testing as the primary outcome. the primary outcome will be the proportion of participants who get tested within 180 days. participants will be randomized to the chatbot group and tau group. participants in the intervention group will get access to an ai-chatbot and can interact with the ai-chatbot at any time. in each round of the interactive communication, the chatbot will provide automated personalized messages containing pre-exposure prophylaxis (prep), mental health, or hiv testing-related information, motivation and skills based on the participants' answers and will continuously update over time. the participants assigned to the tau group will get access to an attention-chatbot and can interact with the attention-chatbot at any time. in each round of the interaction, the chatbot will provide pre-scripted time-attention health education messages to the participants. in addition to the above interventions, the research assistant will manually sent to the participants' phone a piece of educational material and an online survey link every 30 days (at days 30, 60, 90, 120, 150 and 180). the primary outcome of hiv testing will be collected through the survey.

Eligibility criteria:
inclusion criteria: * cis-gender male * condomless sex with men in the past 6 months * hiv status unknown or previously tested negative * speaks bahasa malaysia or english. exclusion criteria: * does not have a smartphone * hiv status previously tested positive * cannot speak bahasa malaysia or english
antibiotic prophylaxis for endoscopic ultrasound guided fine needle aspiration of pancreatic cystic lesions

Conditions: Pancreatic Cystic Lesion

Summary: the purpose of this study is to determine whether the use of antibiotic prophylaxis is appropriate when performing a pancreatic cyst fine needle aspiration guided by endoscopic ultrasonography.

the incidence of infection after a pancreatic cyst fine needle aspiration guided by endoscopic ultrasonography (eus-fna) is not well known. antibiotic prophylaxis is recommended in clinical guidelines despite the lack of evidence of its usefulness. our hypothesis is that the risk of infection will not be higher with placebo, and risks associated to the use of antibiotics might even increase with the use of prophylaxis. the main objective of the project is to assess the risk of infection after the procedure and to determine whether the use of antibiotic prophylaxis is appropriate. the study is a phase iv, multicenter, double-blinded, randomized, placebo-controlled, and non-inferiority trial . we have designed a study with two parallel treatment groups. patients will be randomized to the prophylaxis or to the placebo group. all patients will be followed for 21 days or until resolution of complications. to evaluate this primary objective with a non inferiority study, we have estimated that a total of 218 patients will be needed (109 per group) . the main secondary objective is to assess the incidence of complications related to the use of antibiotic prophylaxis (i.e. allergic reactions, secondary infections or drug-resistant infections).

Eligibility criteria:
inclusion criteria: * patients with a pancreatic cyst requiring eus-fna to complete evaluation. * participant is willing and able to give informed consent for participation in the study. * age 18 years or older. * ability to understand study procedures and to comply with them for the entire length of the study. exclusion criteria: * patients with other co-morbidities requiring antibiotic prophylaxis for endoscopic invasive procedures (such as those with cardiac valve prosthesis). * cystic lesion of the intestinal wall (foregut or duplication cyst). * use of antibiotic treatment for any other indication during the 5 days prior to the procedure. * pregnant woman. * known allergy/sensitivity to ciprofloxacin. * inability or unwillingness of individual or legal guardian/representative to give written informed consent.

Keywords: cyst pancreatic cyst eus-fna antibiotic prophylaxis
different modalities of aquatic physiotherapy in patients with knee osteoarthrosis

Conditions: Osteoarthritis of the Knee

Summary: the aim of this study is to evaluate the effects of different modalities of aquatic physiotherapy on the biochemical and functional behavior of patients with knee's osteoarthritis.

the subjects will be informed about the study and its potentials risks and sign the informed consent. the sample will be submitted to three different modalities of af interventions: (a) low impact immersion, (b) conventional aquatic physiotherapy and (c) high intensity aquatic physiotherapy. the functional variables of flexibility, pain, joint volume will be evaluated before and immediately after each intervention whereas the biochemical variables will be evaluated from the analysis of peripheral blood following times: baseline moment (immediately before the intervention), moment 1 (immediately after the intervention), and moment 2 (24 hours after the intervention).

Eligibility criteria:
inclusion criteria: * patients over 50 years old and diagnosed with oa in at least one knee * presence of pain and at least one functional dysfunction for at least 6 months * absence of physical limitation that prevents the exercise protocol from being performed * kellgren and lawrence ranking between i and iv * walk independently and without auxiliary device exclusion criteria: * inflammatory, rheumatic or autoimmune conditions * use of psychotropic, immunosuppressive and steroid medications * antioxidant consumption * alcohol and tobacco consumption * progressive ankylosis states * neurological injuries * infections or skin diseases that contraindicate swimming pool immersion * surgical procedures on the knee joint in the last 12 months (excluding meniscectomy or arthroscopy) * lower limb joint prosthesis * presence of inflammatory or infectious diseases, uncontrolled systemic arterial hypertension, uncontrolled diabetes, chronic obstructive pulmonary disease and history of ischemic heart disease * self-report of aquatic phobia and chlorine allergies

Keywords: osteoarthritis hydrotherapy
hope at heart (hope) of donor hearts after circulatory death (dcd) using the xvivo heart assist transport system.

Conditions: Heart Failure

Summary: the purpose of the clinical investigation is to support the use of direct procurement of donor hearts in donation after circulatory death followed by hypothermic oxygenated perfusion using the xvivo heart assist transport system. thereby increasing the utilization of dcd donor hearts in donation after circulatory death. the primary objective is to evaluate patient survival after direct procurement and hypothermic oxygenated machine perfusion of dcd donor hearts using the xvivo heart assist transport system. the secondary objectives are to evaluate patient outcomes and graft function post-transplant.

this is a prospective, single-arm, multi-national, multicentre, proof-of-concept study to evaluate post-transplant outcomes after the use of direct procurement followed by a period of hypothermic oxygenated perfusion of the donor heart in dcd using the xvivo heart assist transport system. the investigation will be conducted at 4 heart transplant centres, one in belgium and three in the netherlands.the study will include 20 dcd heart transplant recipients and will evaluate transplant outcomes such as post-transplant complications, patient survival and graft function for a period of 6 months post-transplant. the study will not include a control group as this is a proof-of-concept study, investigating an alternative method of procurement of dcd hearts by providing additional safety and performance data. the primary objective is to evaluate patient survival after direct procurement and hypothermic oxygenated machine perfusion of dcd donor hearts using the xvivo heart assist transport system. the secondary objectives are to evaluate patient outcomes and graft function post-transplant.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years 2. signed informed consent form 3. accepted and/or listed for heart transplantation exclusion criteria: 1. not able to understand the information provided during the informed consent procedure 2. previous solid organ transplantation 3. grown-up congenital heart disease 4. dialysis 5. incompatible blood group 6. combined organ transplantation candidates 7. subjects under pre-transplant desensitization protocol (including plasma exchange in conjunction with the transplant surgery) 8. mechanical circulatory support pre-transplantation (except durable left ventricular assist device or intra-aortic balloon pump)
seroma formation after modified radical mastectomy with flap fixation technique in breast cancer patients

Conditions: Breast-cancer

Summary: the goal of this clinical trial is to evaluate the effectiveness of mastectomy flap fixation in breast cancer patients. the main questions it aims to answer are: - to compare seroma formation after mastectomy flap fixation with conventional surgery in breast cancer patients participants will be randomly divided into 2 groups, 1. mastectomy flap fixation 2. conventional surgery with non flap fixation. researchers will record the amount and color of drainage fluid, patient and tumor characteristics, and operative related factor after surgery. researchers will compare with conventional surgery to see if seroma formation, and wound infection.

seroma is collection of blood plasma or lymphatic fluid under skin flap or axillary dead space. it occurred after modified radical mastectomy. patient will have subcutaneous swelling or edema which be confirmed by physical examination or bedside ultrasound. it categorized by common terminology criteria for adverse events version 5.0 for 3 grades. 1. asymptomatic 2. symptomatic with medical intervention or simple aspiration 3. symptomatic with required interventional radiology or operative intervention.

Eligibility criteria:
inclusion criteria: * breast cancer (ca breast) patients plan to modified radical mastectomy * operable case, or resectable case exclusion criteria: * having medical bleeding tendency e.g., idiopathic thrombocytopenia (itp), leukemia, other bleeding disorder * immunocompromised e.g., hiv, systemic lupus erythematosus (sle), liver cirrhosis, immunosuppressive drug * other modified radical mastectomy whom required reconstruction, flap coverage e.g., transverse rectus abdominis musculocutaneous (tram) flap, latissimus dorsi (ld) flap * past history of mammoplasty, augmentation * past history of axillary lymphatic system operation * pregnant women

Keywords: mastectomy flap fixation
physical activity as self-management approach to improve health outcomes in aml

Conditions: Leukemia; Myeloid; Monocytic

Summary: physical activity as a self-management approach to improve health outcomes in acute myeloid leukemia

guided by the information-motivation-behavioral skills model and using a quasi-experimental cohort control research design, the primary aim of this study is to: determine the feasibility of the biobehavioral self management approach (bsma) program involving physical activity (pa) in patients receiving consolidation treatment for aml. the primary feasibility outcomes for this aim will be rates of recruitment, refusal, retention and attrition; in addition investigators will test methods and procedures of the prescribed bsma pa program, including assessing adherence, participant acceptance and perceived benefit.

Eligibility criteria:
inclusion criteria: * ≥18 years * diagnosis of aml * hospitalized for consolidation chemotherapy within 1 day (+/- 2 days) * read and write in english * able to stand independently * not experiencing psychiatric neurological disorders (assessed through clinical team members) that would prevent obtaining consent. exclusion criteria: * currently experiencing psychiatric or neurologic disorders that would prevent their ability to provide consent.
impact of topical antiadhesion therapy on wound healing and postoperative pain after anal surgery

Conditions: Anal Wound

Summary: 2qr-complex is a patented molecule extracted from aloe vera barbadensis leaves that blocks the adhesion of pathogenic microbes to human epithelial cells and tissues \[9\]. anti-adhesion therapy such as 2qr-complex has been suggested as an alternative to antibiotics in the treatment of bacterial infections. 2qr-complex based products have already shown comparable efficacy to antibiotics in treating mucosal infections such as bacterial vaginosis. in the present study we aim to assess the efficacy of 2qr-complex in pain relief and promotion of anal wound healing after anal surgery. we presumed that anal discomfort and prolonged healing after surgery for anal fissure, fistula, and hemorrhoids may in part be due to contamination of the wound with fecal bacteria that colonize at the surgical site. therefore, we assumed that the use of topical anti-adhesive 2qr-complex-based product may serve to minimize this negative impact on wound healing.


Eligibility criteria:
inclusion criteria: * adult patients of either sex with simple anal fistula, chronic anal fissure, or grade iii/iv hemorrhoids will be included. exclusion criteria: * patients with other anal conditions, diabetic patients, patients under steroid or immunosuppressive therapy will be excluded.
obstructive sleep apnea syndrome and attention executive function disturbances

Conditions: Obstructive Sleep Apnea

Summary: studies demonstrate that sleep disturbances are associated with cognitive dysfunction and attention deficit. however the correlation between the severity of obstructive sleep apnea and the degree of cognitive dysfunction was not demonstrated. our hypothesis is that patients suffering from a more severe sleep apnea will demonstrate a greater degree of cognitive dysfunction.

studies demonstrate that sleep disturbances are associated with cognitive dysfunction and attention deficit. however the correlation between the severity of sleep disturbances and the degree of cognitive dysfunction was not demonstrated.we intend to study 80 patients with various degrees of obstructive sleep apnea. all patients will undergo executive cognitive tests as well as tests to assess for levels of depression, anxiety and attention.

Eligibility criteria:
inclusion criteria: 1. apnea hypopnea index\>5 2. age 20 - 70 years exclusion criteria: 1. pregnant women 2. known chronic cardiovascular or pulmonary disease 3. patients s/p cva or brain damage 4. known depression or other psychiatric disorder 5. patients with severe cognitive dysfunction (mmse\<25) 6. patients receiving stimulants, antipsychotic or anti-depression medications
anesthetic depth effects upon immune competent cells

Conditions: Immunotoxicity; Anesthesia; Inert Gas Narcosis

Summary: anesthesia depth affects the proliferation of lymphocytes to nk-cells and memory t-cells effect and the phagocytosis activity of macrophages in healthy patients. asa 1-3 subjects undergoing extended shoulder surgery under continuous regional anesthesia randomly were assigned to a deep or a shallow anesthesia level (bis \ 55) for more than an hour. immune response is measured by lymphocyte proliferation as well as neutrophil and monocyte phagocytosis activity.

blood samples were taken under minimal stress prior to anesthesia induction (t0), recovery (t1) and 12 weeks following hospital discharge (t2) from the respective anesthesia depth level. bispectral index monitoring (bis) was performed from the awake state to complete recovery in all subjects. hemoglobin concentration, leukocyte and lymphocyte counts were determined by routine automated laboratory techniques. lymphocyte proliferation was analyzed by saspa flow cytometry analysis. in brief, 100 µl edta blood were stirred with 10 µl fitc and pe marked antibody mixture containing cd3, cd4, cd8, cd 16, cd45, cd28, cd27, cd 56. monocyte and neutrophil phagocytosis activity was measured separately in macrophages of fresh heparinized whole blood using flow cytometric test kits. proteomics of monocytes was done synchronously.

Eligibility criteria:
inclusion criteria: * enrolment for longer shoulder surgery * consent for the standard anesthesia form in combination with the interscalene plexus block * asa status 1-3 exclusion criteria: * sedative premedication * severe immune deficiency (diabetes, steroid or antihistamine medication, cancer, chemotherapy, * status post transplantation, drug and alcohol abuse), * recent surgery (1 month) or blood transfusion
comparison of corticosteroid dosing regimens after endothelial keratoplasty

Conditions: Fuchs' Dystrophy; Corneal Edema

Summary: graft rejection has traditionally been one of the leading causes of cornea transplant failure. to help prevent rejection, corticosteroid eye drops are used for an extended period after transplant surgery. the purpose of this study is to compare the efficacy and side effects of different corticosteroid dosing regimens after endothelial keratoplasty (cornea transplant) surgery.


Eligibility criteria:
inclusion criteria: * at least 18 years of age * male or female patient who had endothelial keratoplasty procedure within the past 1 to 7 weeks * patient is able and willing to administer eye drops * patient is able to comprehend and has signed the informed consent form. * patient is likely to complete the one-year course of the study exclusion criteria: * a history of a previous rejection episode in the study eye * a patient exhibiting intraocular inflammation * a patient with a known sensitivity to any of the ingredients in the study medications * a patient who has a condition (i.e., uncontrolled systemic disease) or is in a situation which in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study * a patient with abnormal eyelid function. * a patient that is exhibiting active corneal ulceration, keratitis, or conjunctivitis, or who has a history of herpetic keratitis. * presence of any ocular disease that would interfere with the evaluation of the study treatment. however, patients with a history of cystoid macular edema, age-related macular degeneration, controlled glaucoma, corneal neovascularization, and other non-interfering comorbidities may be enrolled. * a patient with a history of non-compliance with using prescribed medication. * a patient who is concurrently involved in or participated in another randomized clinical trial within 30 days prior to enrollment in this study. * patients who are pregnant or planning to become pregnant within the duration of the study